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Clinical Trial Associate - Switzerland
Debio Pharm (company)
Posted on : 14 May 2017
- Our company is a global biopharmaceutical group including five companies active in the life science areas of drug development, GMP manufacturing of proprietary drugs, diagnostic tools and investment management.
- Our company is focused on the development of prescription drugs that target unmet medical needs.
- The company in-licenses and develops promising drug candidates.
- The products are commercialized by pharmaceutical out-licensing partners to give access to the largest number of patients worldwide.
- For our Clinical Research & Development Department , we are looking for a Clinical Trial Associate(12-month contract)
Your main responsibilities
- Support Clinical Trial Managers in daily operational activities related to clinical trials with external vendors (CRO) and internal stakeholders;
- Generate, finalize and distribute study team agenda and meeting minutes in a timely manner. Act as a support to the CTM for meeting preparation;
- Collect, verify and upload documents into eRoom (Sharepoint) under the responsibility of the CTM.
- Ensure a clear and consistent structure and filing method;
- File and archive all study documents on the eTMF platform under the responsibility of the CTM and ensure inspection readiness of the TMF;
- Follow up of study budget, preparation and update of purchase orders including management of study invoices;
- Update and/or track study reporting tools (e.g. weekly follow-up chart, Export of the CRO reporting tool, CTMS);
- Participate in clinical operations initiatives to reach increased quality, productivity and study management efficiency;
- Depending on studies:
- Create and distribute documents for study sites such as study binders;
- Prepare regulatory files for submission to Health Authorities and Ethics Committees;
- Contribute to transversal activities such as ClinicalTrials.gov registrations, clinical trial insurances, etc.
- University/College degree level or equivalent in a relevant discipline.
- Proven track record of 3-5 years of experience as CTA or comparable operating experience in Pharma/CRO/healthcare with good knowledge of budget and invoicing requirement, as well as drug development process and medical terminology.
- Experience in Management and filing of Trial Master File content (Veeva Vault experience is a plus)
- Excellent spoken and written English and French.
- Customer orientation and Team spirit, with ability to foster a collaborative team environment in a fast paced matrix organization;
- Ability to communicate with cross-functional teams.
- Strong organizational skills with ability to manage stress, pressure and deadlines.
- Good to advanced computer skills with requirement of MS applications.
- An international and highly dynamic environment.
- The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry.
- The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success